NCT00588263

Brief Summary

The intent of the proposed study is to describe the prevalence of the most common recurring mutations in BRCA1 and BRCA2, blmAsh , and the A636P MSH2 mutation among Ashkenazi Jewish individuals with a variety of cancer diagnoses. If a substantial proportion of these samples contain such mutations, future patients presenting with these diseases may wish to undergo genetic counseling and, if appropriate, formal genetic testing. The benefit from such a process would pertain mainly to the families of these individuals.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 8, 2008

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

February 19, 2018

Status Verified

August 1, 2017

Enrollment Period

18 years

First QC Date

December 22, 2007

Last Update Submit

February 14, 2018

Conditions

Extrahepatic Bile Duct CancerGallbladder CancerGastric CancerLung CancerMelanomaNon-Hodgkin's LymphomaUterine CancerCORPUS UTERI,ENDOMETRIUMLUNGOVARY

Keywords

Ashkenazi JewishCancer00-087

Outcome Measures

Primary Outcomes (1)

  • determine the prevalence of recurring BRCA1 and BRCA2 mutations

    5 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cases will be identified in one of two ways. Pathology records will be reviewed for the years 1985-present. All patients with diagnoses of pancreatic cancer, uterine cancer,lymphoma, melanoma, cancer of the gallbladder and bile duct, stomach cancer, brain cancer, ovarian cancer, colon cancer, head and neck cancer, lung cancer and breast cancer(including DCIS) from 1985 to the present at MSKCC will be identified.

You may qualify if:

  • Diagnosis of cancer made at MSKCC or collaborating institutions, AND
  • Tissue block of tumor or normal margin or extracted DNA available for study and sufficient material present to allow study without exhausting block or DNA,
  • Individual self-identified as Jewish on intake.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blocks or extracted DNA from patients who have identified themselves as Jewish will be obtained and a determination will be made as to whether there is adequate material to proceed without exhausting the block or extracted DNA. Four unstained sections (research specimens) or paraffin "curls" will be cut from each block. In those cases where a block containing normal resection margin or any other biopsy of normal tissue are available, tissue will be cut from this block so as to preserve tumor tissue for later investigators. It is not necessary for sections to be reviewed to confirm that tumor is present in the section, since any germline DNA is adequate for this analysis.

MeSH Terms

Conditions

Bile Duct NeoplasmsGallbladder NeoplasmsStomach NeoplasmsLung NeoplasmsMelanomaLymphoma, Non-HodgkinUterine NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesStomach DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesLymphomaLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Kenneth Offit, M.D.

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2007

First Posted

January 8, 2008

Study Start

July 1, 2000

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

February 19, 2018

Record last verified: 2017-08

Locations

US(1)